FDA approves new treatment for FOP
Total new heterotopic ossification volume decreased with treatment and increased with placebo at week 24.
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By
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Kathryn Wighton
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September 28, 2026
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The FDA approved zilurgisertib (Atebrioz) for reducing heterotopic ossification in patients with fibrodysplasia ossificans progressiva.
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Fibrodysplasia ossificans progressiva is a rare genetic disease caused by a mutation in the activin A receptor-type 1.
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Zilurgisertib was evaluated in a trial with 63 patients, showing a mean decline in ossification volume compared to placebo.
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Common adverse effects of zilurgisertib include headache, joint pain, and upper respiratory tract infections.
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Zilurgisertib received fast track, priority review, and orphan drug designations from the FDA for its indication.